Gilead Sciences announced the discontinuation of the phase III ENHANCE-3 study, which was evaluating magrolimab in acute myeloid leukemia (AML). Additionally, the U.S. Food and Drug Administration placed all magrolimab studies in myelodysplastic syndromes (MDS) and AML on hold.
ENHANCE-3 was evaluating magrolimab versus placebo in combination with venetoclax plus azacitidine in patients with newly diagnosed AML. Participants were required to be previously untreated and ineligible for intensive chemotherapy.
The discontinuation was issued based on the results of an interim analysis of the trial as well as the data from the ENHANCE and ENHANCE-2 studies that demonstrated futility and increased risk of death.
ENHANCE-3 patients will discontinue magrolimab treatment, and the company will no longer pursue development of the treatment in hematologic cancers, Gilead said in a press release.
“The complexity of treating blood cancer is highlighted in these results,” said Merdad Parsey, MD, PhD, chief medical officer for Gilead Sciences. “We are incredibly grateful to all the patients and investigators for their participation in the ENHANCE studies.”
Source: Gilead Sciences, February 7, 2024.
